Development and validation of a Reverse Phase-HPLC method for the determination of Rosiglitazone Maleate in tablet dosage form
By S.Gopalakrishnan, E.Vadivel, M.Karthika and B. Jeyashree
A rapid reverse phase high performance liquid chromatography method has been developed and validated for the determination of Rosiglitazone maleate in tablets. Isocratic chromatography was performed on a Kromasil C18 (250X4.6mm) with buffer:acetonitrile:methanol in the ratio of 65:25:10 as a mobile phase at a flow rate of 1.0 ml min-1 and the detection was monitored out by photodiode array detector at 235 nm. The retention time for Rosiglitazone maleate was found to be 5.720 min. Good linearity was demonstrated in the range of 160-260 μg/ml (r~0.9975). Various chromatographic parameters including precision, accuracy, system suitability, specificity, LOD, LOQ and robustness have been evaluated. The proposed method was statistically evaluated and can be applied for routine quality control analysis of Rosiglitazone maleate
Keywords: RP-HPLC, Rosiglitazone maleate, Validation, Anti-diabetic, Isocratic.